Safety and Pregnancy Outcomes in Thrombocythemia Patients Exposed to XAGRID® (Anagrelide Hydrochloride) Compared to Other Treatments

Shire

Status: Completed

Conditions: Thrombocythemia, Essential

Study type: Observational

Funder types: Industry

Identifiers

NCT00567502

SPD422-401

Details and patient eligibility

About

This is an observational safety study being conducted in Europe comparing patients taking Xagrid to patients taking other cytoreductive treatments. The plan is to enrol at least 750 subjects taking Xagrid with up to 3000 subjects taking other cytoreductive therapies. The study will collect follow up data for 5 years for each patient enrolled that will focus on collecting data related to pre-defined events (PDEs) and Suspected Serious Adverse Reactions (SSARs).

Enrollment: 3,647 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• High risk ET patients
• Subjects who can give written informed consent.
• Subjects taking cytoreductive therapy

Exclusion criteria

• Contraindications listed by the product being used.
• Patient cannot be participating in another clinical trial.

Trial design

3,647 participants in 3 patient groups

1

Description:

XAGRID® (anagrelide hydrochloride)

2

Description:

Xagrid + Other cytoreductive

3

Description:

Other cytoreductive